← Back to catalogue
Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method)
EUDAMEDFDA 510(k)Class IVD General (EU MDR)
Ref DTSH060702CModel R1: 20 mL × 1, R2: 5 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH060703Model R1: 60 mL × 1, R2: 15 mL × 1Ref DTSH060701CModel R1: 60 mL × 3, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH060705CModel R1: 80 mL × 3, R2: 20 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1Ref DTSH060704Model R1: 40 mL × 3, R2: 30 mL × 1Ref DTSH060703CModel R1: 60 mL × 1, R2: 15 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 1
Identity
- Device Name
- Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method) EUDAMED
- Model / Reference
- R1: 20 mL × 1, R2: 5 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH060702C EUDAMEDR1: 60 mL × 1, R2: 15 mL × 1 EUDAMEDDTSH060703 EUDAMEDR1: 60 mL × 3, R2: 15 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH060701C EUDAMEDR1: 80 mL × 3, R2: 20 mL × 3 Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH060705C EUDAMEDR1: 40 mL × 3, R2: 30 mL × 1 EUDAMEDDTSH060704 EUDAMEDR1: 60 mL × 1, R2: 15 mL × 1 Calibrator: 1 mL × 1; quality control: 1 mL × 1 EUDAMEDDTSH060703C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225463296 EUDAMED06975225463302 EUDAMED06975225463357 EUDAMED06975225463371 EUDAMED06975225463326 EUDAMED06975225463319 EUDAMED
- Basic UDI-DI
- B-06975225463296 EUDAMEDB-06975225463302 EUDAMEDB-06975225463357 EUDAMEDB-06975225463371 EUDAMEDB-06975225463326 EUDAMEDB-06975225463319 EUDAMED
- EMDN Code
- W0102010405 LIPOPROTEIN ( A ) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Apolipoprotein B (Apo B) IVD, reagent
Lipoprotein (a) Assay Kit (Latex Immunoturbidimetric Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — FDA_510K, IVDD — listed in…
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, reagent.
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Lipoprotein (a) — Diagam S.A. · IVD General
- Apolipoprotein B Reagent (ApoB 2 x 100) — Beckman Coulter, Inc. · IVD General
- Lipoprotein (a) Kit (Latex-Enhanced Immunoturbidimetric Method) — MEDICALSYSTEM BIOTECHNOLOGY CO., LTD. · IVD General
- APO B — Medicon Hellas SA · IVD General
- Lipoprotein (a) (Lp(a)) Kit(Immunoturbidimetric Method) — Zybio Inc. · IVD General
- Nephstar Apo B Kit — Goldsite Diagnostics Inc. · IVD General
- Lipoprotein (a) Kit (Latex Immunoturbidimetric Method) — Shenzhen Mindray Bio-Medical Electronics Co.,LTD · Class B
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063838 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06975225463296 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (7)
- EUDAMED c777fe84-91fe-40e4-91b9-f51423dabadc 61 fields · synced Jul 30, 2026
- EUDAMED 759f38e0-e39f-455f-abb4-172825516dc4 61 fields · synced May 17, 2026
- EUDAMED d2761375-43eb-493f-bb3f-5df8a2b52782 61 fields · synced May 17, 2026
- EUDAMED 925f3f62-c0ad-4c39-85ea-868315876ed6 61 fields · synced May 18, 2026
- EUDAMED 92521068-c847-484b-aa38-3d73aced1455 61 fields · synced May 18, 2026
- EUDAMED f410e339-ea33-4bee-a99f-05a7e4893375 61 fields · synced May 18, 2026
- FDA 510(k) K063838 1 fields · synced May 18, 2026